• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

FDA Authorizes First At-Home COVID-19 Test, Results in 30 Mins or Less

by Fred Pennic 11/18/2020 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
FDA Authorizes First At-Home Molecular COVID-19 Test

What You Should Know:

– FDA approves emergency use authorization (EUA) for Lucira Health’s all-in-one-test kit for COVID-19 self-testing at home.

– The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes.


On late Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop-mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.

Why It Matters

By current national estimates, up to 50 to 100 million COVID-19 tests may need to be conducted each month in the United States, with as many as 900 million totals possible through 2021. If all U.S. airline passengers were also tested, that would require one billion tests annually. Likewise, if the country’s health care workers were tested weekly for a year, that would also require around one billion tests. A variety of tests have been developed to help meet this need, with Lucira being the latest and first to get FDA authorization for prescription self-testing at home molecular diagnostic test.

Authorized for Prescription Use Only

The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.

How It Works

The streamlined Lucira COVID-19 All-In-One Test Kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes. The Lucira COVID-19 All-In-One Test Kit comes with everything needed to perform a single COVID-19 test. Users open the box containing the test device, sample vial, swab, and simple instructions. Two AA batteries are inserted in the device and the sample vial is placed in the test unit.

Next, the user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial and then pressed down in the test unit to start the test. The “ready” light will blink until a “positive” or “negative” green light is illuminated within 30 minutes. For guidance on care and public health reporting, patients will report their test results to the medical office that prescribed the test

Availability

The Lucira ™COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers and is expected to cost around $50.

By the second quarter of 2021, Lucira Health plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a dedicated website to arrange a prescription and overnight delivery of the test kit, if approved. Follow-up monitoring will be available for public health reporting so people can get additional guidance and information if needed.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Coronavirus (COVID-19)

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Interview

Reach7 Diabetes Studios Founder Chun Yong on Reimagining Chronic Care with a Concierge Medical Model

Most-Read

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

HHS Finalizes HTI-4 Rule: Prior Authorization & E-Prescribing Interoperability

Meaningful Use Penalties_Meaningful Use_Partial Code Free_Senators Urge CMS to Establish Clear Metrics for ICD-10 Testing

CMS Finalizes TEAM Model: A New Era of Value-Based Surgical Care

White House Event Unveils CMS Health Tech Ecosystem Initiative

White House Event Unveils CMS Health Tech Ecosystem Initiative

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low, But AI Dominates and $1B+ IPOs Emerge

Healthcare Investment Shifts in 1H 2025: AI Remains a Bright Spot Amidst Fundraising Decline

Digital Health Faces Q2'25 Pullback: Funding Falls to 5-Year Low

Digital Health Faces Q2’25 Pullback: Funding Falls to 5-Year Low

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Beyond the Hype: Building AI Systems in Healthcare Where Hallucinations Are Not an Option

Health IT Sector Navigates Policy Turbulence with Resilient M&A

Health IT’s New Chapter: IPOs Return, Resilient M&A, Valuations Rise in 1H 2025

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

PwC Report: US Medical Cost Trend to Remain Elevated at 8.5% in 2026

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

Philips Launches ECG AI Marketplace, Partnering with Anumana to Enhance Cardiac Care with AI-Powered Diagnostics

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

WeightWatchers Emerges from Bankruptcy, Launches New Menopause Program

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |